NMPA (CFDA) Updates

January 18, 2021

Another AI Software Approved by NMPA

NMPA granted Innovative Device Approval to the CT Imaging Assisted Pulmonary Nodule Detection Software produced by Hangzhou Deepwise on December 1, 2020. This is the second AI innovative product approved by […]
January 18, 2021

NMPA Released 12 Guidelines in One Day

NMPA published twelve guidelines on December 9, 2020. Among all the guidelines, seven of them are for IVD products and five are for nomenclature. The guidelines are put in place […]
January 18, 2021
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NMPA Down-Classified Seven Class III Medical Devices

NMPA released the updated Medical Device Classification Catalog on December 31, 2020, providing modification on management category and device classification. Complete List 15 medical devices are down-classified, including seven class […]
January 18, 2021

Feedbacks Needed for DR and Ultrasonic Diagnostic Software

NMPA announced its preparation of “Technical Review Guideline of Diagnostic Software for Diabetic Retinopathy (DR)” and “Technical Review Guideline of Image Ultrasonic Diagnostic Based AI Software” for public comments on December […]
January 15, 2021

China UDI Submission Taking Effect Jan 1, 2021

China UDI system for the first group of devices  will take effect on January 1, 2021. For the medical devices listed in the “First Group of Unique Device Identification Devices”, […]
January 15, 2021

Fourteen Medical Devices Go into Hainan RWD Pathway

Fourteen medical devices and three drugs are piloting in the Real-World Data (RWD) Program in Hainan, according to RWD Initiation Meeting in Beijing on December 28, 2020. It is the […]
January 10, 2021

Historical Changes of Medical Device Announced December 2020

Historical changes of medical device industry has been made in China. Amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted by the China State Council […]
December 23, 2020

In Beijing, One Center Ethics Committee Review is Sufficient for Multicenter Study

A “Beijing Medical Ethics Committee (EC) Review Mutual Recognition Alliance” was formed on December 1, 2020. The mutual recognition alliance currently consists of fifteen member institutes. It will greatly accelerate […]
December 23, 2020

Another Special Region for Unapproved Device Usage in China—”Big Bay Area”

Unapproved medical devices can be clinically used in China’s Big Bay Area of Guangdong, Hong Kong, and Macao with over 70 million people. As long as they are used in […]
December 9, 2020

NMPA Reviewers’ Evaluation Key Points on Peripheral Drug-Eluting PTA Balloon Catheter Revealed

The NMPA granted Innovation Approval for a Peripheral Drug-Eluting PTA Balloon Catheter produced by Zylox Medical on November 11, 2020. For the NMPA Innovation Device Review Report on the Peripheral Drug-Eluting […]
December 9, 2020

Guangdong Becomes Second Province to Import Unapproved Medical Device

“The designated medical institutions in the region can use medical devices that are urgently needed for clinical use, and have been purchased and used by public hospitals in Hong Kong […]
December 4, 2020

Draft Guideline for Overseas Clinical Data Acceptance on IVD: Nine Types of Differences to Pay Attention

NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostic (IVD) (draft)” for comments on November 25, 2020. Feedback needs to be submitted by December 15, 2020. Differences between […]